Know Cancer

or
forgot password

Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy


This is a prospective pragmatic trial randomizing women diagnosed with early stage breast
cancer to MRI versus no breast MRI. Data analyzed will include medical record information
abstracted from the clinical records. Date and modality of all imaging performed,
malignancy(s) identified, abnormalities identified, image guided procedures performed,
surgical procedures performed and pathology results.

The primary aim of this study is to assess if the use of pre-operative MRI can reduce the
incidence of re-excisions required to achieve clear margins in women with newly diagnosed
early stage breast carcinoma.


Inclusion Criteria:



- Must undergo definitive local therapy with either breast conserving therapy or
mastectomy

- Clinical Stage 0, I or II breast cancer based on examination and/or conventional
imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in
size and the patient clinically node negative

- Able to undergo breast MRI

Exclusion Criteria:

- Not pregnant or breastfeeding

- No prior breast MRI for the newly diagnosed carcinoma at the outside hospital

- No prior mantle radiation

- No locally advanced breast cancer

- No diffuse malignant appearing microcalcifications requiring mastectomy

- No known collagen vascular disease

- No previous ipsilateral radiation

- No participants who undergo surgery at an outside institution

- No prior history of breast carcinoma

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Assess if pre-operative MRI reduces incidence of re-excisions required

Outcome Description:

Assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

11-330

NCT ID:

NCT01568346

Start Date:

February 2012

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Newly diagnosed
  • Early stage
  • Breast Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Faulkner HospitalJamaica Plain, Massachusetts  02130